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CA2398035A1 - Timed pulsatile drug delivery systems - Google Patents

Timed pulsatile drug delivery systems Download PDF

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Publication number
CA2398035A1
CA2398035A1 CA002398035A CA2398035A CA2398035A1 CA 2398035 A1 CA2398035 A1 CA 2398035A1 CA 002398035 A CA002398035 A CA 002398035A CA 2398035 A CA2398035 A CA 2398035A CA 2398035 A1 CA2398035 A1 CA 2398035A1
Authority
CA
Canada
Prior art keywords
beads
membrane
time
pharmaco
duration
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002398035A
Other languages
French (fr)
Other versions
CA2398035C (en
Inventor
Phillip J. Percel
Gopi M. Venkatesh
Krishna Vishnupad
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Adare Pharma Solutions Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2398035A1 publication Critical patent/CA2398035A1/en
Application granted granted Critical
Publication of CA2398035C publication Critical patent/CA2398035C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/18—Sulfonamides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Electric Clocks (AREA)
  • Indexing, Searching, Synchronizing, And The Amount Of Synchronization Travel Of Record Carriers (AREA)
  • Television Signal Processing For Recording (AREA)

Abstract

A pharmaceutical dosage form such as a capsule capable of delivering therapeutic agents into the body in a time--controlled or position-controlled pulsatile release fashion, is composed of a multitude of multicoated particulates (beads, pellets, granules, etc.) made of one or more populations of beads. Each of these beads except an immediate release bead has at least two coated membrane barriers. One of the membrane barriers is composed of an enteric polymer while the second membrane barrier is composed of a mixture of water insoluble polymer and an enteric polymer.
The composition and the thickness of the polymeric membrane barriers determine the lag time and duration of drug release from each of the bead populations. Optionally, an organic acid containing intermediate membrane may be applied for further modifying the lag time and/or the duration of drug release. The pulsatile delivery may comprise one or more pulses to provide a plasma concentration-time profile for a therapeutic agent, predicted based on both its pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.
CA002398035A 2000-02-11 2001-02-08 Timed pulsatile drug delivery systems Expired - Fee Related CA2398035C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US18186700P 2000-02-11 2000-02-11
US60/181,867 2000-02-11
PCT/US2001/004012 WO2001058433A1 (en) 2000-02-11 2001-02-08 Timed pulsatile drug delivery systems

Publications (2)

Publication Number Publication Date
CA2398035A1 true CA2398035A1 (en) 2001-08-16
CA2398035C CA2398035C (en) 2008-08-05

Family

ID=22666138

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002398035A Expired - Fee Related CA2398035C (en) 2000-02-11 2001-02-08 Timed pulsatile drug delivery systems

Country Status (14)

Country Link
US (2) US6627223B2 (en)
EP (1) EP1123700B1 (en)
JP (2) JP4991072B2 (en)
CN (1) CN1404389B (en)
AT (1) ATE266390T1 (en)
AU (1) AU772168B2 (en)
CA (1) CA2398035C (en)
DE (1) DE60103186T2 (en)
ES (1) ES2220602T3 (en)
HK (1) HK1039569B (en)
MX (1) MXPA02007762A (en)
NZ (1) NZ520706A (en)
PT (1) PT1123700E (en)
WO (1) WO2001058433A1 (en)

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